Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06104592
Phase
PHASE2
Status
Recruiting
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Conditions

  • Large B-cell Lymphoma
  • Relapsed Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Comprehensive Ablative Bridging Irradiation (CABI) — RADIATION
    Participants will receive radiation therapy to all pretreatment lesions that are able to be feasibly and safely treated.
  • Chimeric Antigen Receptor T-Cell Therapy — BIOLOGICAL
    Yascarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help the T cells recognize cancer cells. The reengineered T cells are infused back into the patient to attack the cancer.

Study Details

This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm.

Key Dates

Start date
Nov 8, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation Therapy and CAR T-Cell Infusion
    Following T-cell apheresis for CD19 CAR T-cell therapy, eligible enrolled study participants patients will undergo Comprehensive Ablative Bridging Irradiation (CABI) to all pretreatments lesions that are able to be feasibly and safely treated by the treating radiation oncologist. Upon completion of bridging radiotherapy, patients will undergo lymphodepleting chemotherapy period (Days -5, -4, -3) followed by axi-cel infusion (Day 0).

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: at 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Michael Jain, MD, PhD (PRINCIPAL_INVESTIGATOR)
Nicholas Figura, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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